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EMA to review marketing authorization application of biosimilar to candidate to Humira

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The European Medicines Agency has accepted to review the marketing authorization application for the adalimumab biosimilar candidate FKB327 for the treatment of patients with rheumatoid arthritis, according to a company press release.

“We are delighted that [Europpean Medicines Agency] EMA has accepted this application,” Hideaki Nomura, president and chief executive officer of Fujifilm Kyowa Kirin Biologics, said in the release. “The acceptance of this filing brings us one step closer to meeting the demand for high-quality and affordable biopharmaceuticals.”

According to the release, the authorization review will be based on results from the phase 3 trial of FKB327, which showed no significant differences with Humira (adalimumab, AbbVie) regarding the adverse event rate.

Reference:

fujifilmkyowakirin-biologics.com/en/